Congenital Hyperinsulinism Clinical Trial
Official title:
18F-Fluoro-L- DOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism
The goal of this project is to determine the role of FDOPA/PET as a pre-operative diagnostic imaging procedure for differentiating focal and diffuse forms of congenital hyperinsulinism and locating focal lesions in the pancreas to guide surgical resection.
Congenital hyperinsulinism (HI) is the most common cause of recurrent and persistent hypoglycemia, presenting early in infancy. Patients who fail medical therapy usually require resection of the diseased pancreas(partial or subtotal pancreatectomy) to control this disorder. Over half of patients undergoing surgery have a focal area of islet cell dysfunction that is curable with resection. These focal lesions are areas of adenomatosis consisting of a clone of beta-cells that express a paternally-derived mutation of the KATP channel due to loss of heterozygosity for the maternal allele. Current imaging techniques cannot differentiate focal and diffuse forms of hyperinsulinism, nor can they locate focal areas of disease within the pancreas before surgery. L-DOPA is taken up by some neuroendocrine cells, including pancreatic islet cells, and stored as dopamine in secretory granules. Recent studies show that positron emission tomography (PET) following administration of 18F-fluoro-L-DOPA (FDOPA) can distinguish focal and diffuse forms of HI and accurately locate focal lesions within the pancreas. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02021604 -
Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma
|
Phase 1 | |
| Recruiting |
NCT04732416 -
HM15136 Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)
|
Phase 2 | |
| Completed |
NCT02937558 -
CSI-Glucagon for Prevention of Hypoglycemia in Children With Congenital Hyperinsulinism
|
Phase 2 | |
| Completed |
NCT02604485 -
A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism
|
Phase 2 | |
| Completed |
NCT00897676 -
Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity
|
Phase 1/Phase 2 | |
| Completed |
NCT00987168 -
Sandostatine® LP and Hyperinsulinism
|
Phase 2 | |
| Active, not recruiting |
NCT03941236 -
Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism
|
Phase 3 | |
| Completed |
NCT03042416 -
18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety
|
Phase 3 | |
| Completed |
NCT04172441 -
Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
|
Phase 2/Phase 3 | |
| Recruiting |
NCT04706910 -
18F-DOPA II - PET Imaging Optimization
|
Phase 3 | |
| Recruiting |
NCT06208215 -
RZ358 Treatment for Congenital Hyperinsulinism
|
Phase 3 | |
| Completed |
NCT03777176 -
A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
|
Phase 3 | |
| Recruiting |
NCT03768518 -
GLP-1 Receptor Expression in CHI
|
||
| Completed |
NCT04538989 -
An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism
|
Phase 2 | |
| Completed |
NCT01070758 -
Lanreotide Autogel Treatment of Patients With Congenital Hyperinsulinism of Infancy
|
Phase 4 | |
| Completed |
NCT00674440 -
Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism
|
Phase 2 | |
| Terminated |
NCT00835328 -
Effect of Exendin (9-39) on Glucose Requirements to Maintain Euglycemia
|
Phase 1/Phase 2 | |
| Completed |
NCT00571324 -
Effect of Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT03053284 -
Pasireotide in Hyperinsulinemic Hypoglycemia
|
Phase 2 | |
| No longer available |
NCT02835131 -
Compassionate Use of SOM230 for Hyperinsulinemic/Hypoglycemia
|